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Crohn’s Patients Gain Quality of Life with New Treatment Plan

Researchers at the Mayo Clinic say the new therapeutic approach to Crohn’s disease they’ve developed brings more “opportunity for remission” and “significant improvement in quality of life” for the 500,000 Americans estimated to have this inflammatory disorder that affects the gastrointestinal tract.  The research team presented its new approach earlier today at the 2008 annual meeting of the American College of Gastroenterology (ACG).

At this time, there is no cure for Crohn’s disease, which causes abdominal pain, diarrhea, fever, nausea, vomiting, and undesirable weight loss.  The traditional course of treatment begins with steroids, then advances to azathioprine and then monoclonal antibodies as the disease progresses.

William Sandborn, MD, the Mayo Clinic gastroenterologist who led the study, shifted the course of treatment a bit by adding infliximab, a monoclonal antibody, either before azathioprine therapy began or in combination with the azathioprine.  The team’s findings indicate treatment strategies based on infliximab are both safe and more effective than those using azathioprine alone.

Infliximab, marketed as Remicade, blocks tumor necrosis factor, a protein that destroys the abnormally growing cells that cause gastrointestinal inflammation.  Effective infliximab therapy requires intravenous infusions given in a series over the course of treatment.  Azathioprine, a broad-spectrum immunosuppressant, may be favored because it is administered orally.

Sandborn’s team gathered data from 508 Crohn’s disease patients at 200+ medical facilities in Europe, Israel, and the United States to explore the different outcomes achieved from taking either infliximab or azathioprine alone or in combination.  Both infliximab-based therapies proved to be statistically superior to the therapy using only azathioprine.

Remission rates achieved by the three therapies were:

• 57% of the combo therapy group enjoyed 26 weeks of remission, entirely free of steroids;
• 44% of the infliximab-only group enjoyed similar remissions; and
• 30% of the azathioprine patients enjoyed these same remissions.

An added benefit of the combo therapy was the 61% rate of mucosal healing this group experienced.  Healing of the bowel, or mucosal healing, is a sign of improved health measured via colonoscopy.  When colonoscopies reveal mucosal healing, patients are less likely to be admitted to a hospital or require surgery than Crohn’s patients not experiencing healing.

Sanborn urges his fellow clinicians to incorporate the infliximab-based therapies into their practices as a means of stimulating mucosal healing.  The bowel healing will allow patients to gain some time during remission periods, which contributes substantially to a patient’s ability to enjoy life.

Centocor, Inc., makers of Remicade (infliximab), provided funding for this study.  The Mayo Clinic receives consulting fees for the work Dr. Sandborn does on behalf of Centocor,  UCB Pharma, and Abbott Laboratories.

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